Phase II: Inhaled SNG001 in COPD subjects

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled Phase II study, comparing the efficacy and safety of inhaled SNG001 to placebo administered to COPD patients after the onset of a respiratory viral infection for the prevention or attenuation of COPD symptoms caused by respiratory viruses

• IRAS ID

  60402

• Contact name

  Ratko Djukanovic

• Sponsor organisation

  Synairgen Research Limited

• Eudract number

  2010-022110-29

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  When people with COPD get a respiratory virus such as a cold or flu it often increases COPD symptoms. We will test the study medication to find out if it can prevent the virus spreading from the nose to the lungs.SNG001 contains Interferon-ç (an antiviral protein) that occurs naturally in the body. Interferon-ç is taken by injection by thousands of multiple Sclerosis patients in this study, SNG001 will be given by a nebuliser. Lung cells of COPD patients do not make enough Interferon-ç when they are infected by the common cold virus. When normal amounts of Interferon-ç are added to the cells they mount an anti-viral response. Patients known to have COPD will be contacted about the study and will be invited to discuss the trial with the study team. If they appear to be suitable and are interested they will be sent the patient information sheet and consent form and will be asked to contact the research team when they develop upper respiratory virus symptoms. When subjects develop upper respiratory virus symptoms they will be invited to attend the clinic to discuss the study and choose to consent if they so wish. Subjects who have consented will undergo screening to ensure that they are eligible to take part in the trial. Eligible subjects will be randomised 1:1 to receive 6 MIU SNG001 or placebo once daily for 14 days. Doses will be delivered in the clinic and at home, by a breath-actuated nebuliser. It is important that the first dose of study medication will be administered within 48 hours of the initial onset of respiratory virus symptoms. Subjects will be assessed for changes in lung function, respiratory virus symptoms and COPD symptoms. Efficacy and safety will be monitored until at least 30 days post end of treatment.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  10/H0504/54

• Date of REC Opinion

  8 Oct 2010

• REC opinion

  Further Information Favourable Opinion